Focused ultrasonic transducer navigation system

ABSTRACT

A focused ultrasonic transducer navigation system attaches to a patient and includes a housing that contains an ultrasonic device. An alignment system moves the housing, and moves the ultrasonic device within the housing, so a focal point of ultrasonic energy from the ultrasonic device is aligned in x, y, and z planes with a target location in the patient. The alignment system realigns the focal point of the ultrasonic device with the same patient target location over multiple therapy sessions eliminating repeated use of an MRI system for repeatedly realigning the ultrasonic device.

BACKGROUND

Ultrasonic energy is used to treat different medical conditions. Duringtreatment, transducers apply ultrasonic energy to a treatment zone or“target” within a patient. For example, the ultrasonic energy may beapplied to a clot to dissolve or remove a blockage within the brain. Ofcourse other types of disorders also may be treated with ultrasonicenergy. For example, ultrasonic therapy may be used for treating otherpsychiatric, neurological, and medical disorders.

Ultrasonic therapy may involve applying ultrasonic energy to the sametreatment zone over multiple treatment sessions. Each treatment sessionneeds to apply the ultrasonic accurately and repeatedly to the sametreatment zone. A Magnetic Resonance Imaging (MRI) machine may firstscan the brain, or other body part, to locate the target area. Theultrasonic system is then adjusted to focus the ultrasonic energy ontothe located target area. Ultrasonic therapy may be time consuming andexpensive since each session requires a trip to a hospital and use of aMRI machine to relocate the same target area.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a focused ultrasonic transducernavigation system.

FIG. 1B is a side view of straps used for attaching the ultrasonictransducer navigation system to a patient.

FIG. 2 is a side view of the ultrasonic transducer navigation system.

FIG. 3 is a partial side sectional view of a top adjustment assembly.

FIG. 4 is a front sectional view of the ultrasonic transducer navigationsystem.

FIG. 5 is a side view of a template used for aligning the ultrasonictransducer navigation system.

FIG. 6 shows reference marks created using the template of FIG. 5.

FIG. 7 is a side view of the ultrasonic transducer navigation systemattached to a patient.

FIG. 8 is a front sectional view of the ultrasonic transducer navigationsystem shown in a lowered position.

FIG. 9 is a front sectional view of the ultrasonic transducer navigationsystem shown in a raised position.

DETAILED DESCRIPTION

FIG. 1A shows a perspective view of a focused ultrasonic TransducerNavigation System (TNS) 100. TNS 100 may be attached to a patient 88 andmay apply ultrasonic energy to precise target locations within patient88. The explanation below discusses the specific example of using TNS100 to apply ultrasonic energy to a target location within head 90 ofpatient 88. However, it should be understood that TNS 100 may apply anytype of sonic, magnetic, or any other alternative energy to any targetlocation within any body part of patient 88. TNS 100 may be used onhuman patients or animal patients.

A housing assembly 102 comprises an outer housing 104 attached to amovable inner housing 106. A transducer (see FIG. 4) may be locatedwithin inner housing 106. A power cable 116 may attach to the transducerand extend up through inner housing 106 and outer housing 104.

A first vertical strap 108C attaches to elevating screws 114 and wrapsaround the top of head 90 and underneath the chin of patient 88. Asecond horizontal strap 108 includes a ring shaped section 108A thatattaches to an outside surface of outer housing 104 via screws 109A andnuts 109B and a headband section 108B that wraps around the front overthe eyes and back of head 90. While shown attached to head 90, it shouldbe understood that straps 108, or other attachment devices, may attachhousing assembly 102 to other body parts of patient 88. The housingassembly 102 may be attached by straps 108 to the right side or leftside of head 90 to apply ultrasonic energy to targets on inside eitherside of head 90.

Three housing arms 112 may extend radially out from sides of outerhousing 104. Elevating screws 114 may rotatably extend through housingarms 112 and may include elastomeric cushions 118 that press up againsthead 90. Elevating screws 114 may be rotated downward pressing againsthead 90 to reduce some of the compressive force of inner housing 106against head 90. This will be described in more detail below.

An alignment system 110 may move the transducer within inner housing 106into different x, y, and/or z positions with respect to head 90. The xposition may refer generally to front to back positions with respect tohead 90, the y position may refer generally to top to bottom positionswith respect to head 90, and the z position may refer generally to atransverse inside to outside, or left to right positions, with respectto head 90.

If TNS 100 were attached on the top of head 90, the x position may referto front to back positions with respect to head 90, the y position mayrefer to the left to right or side to side positions with respect tohead 90, and the z position may refer to the transverse inside tooutward or top to bottom positions with respect to head 90.

Alignment system 110 may comprise side adjustment assemblies 120 and atop adjustment assembly 140 that have the unique ability to move thetransducer within inner housing 106 in different x, y, and z directionswhile TNS 100 remains attached to head 90 of patient 88. This allowsmore precise alignment of the transducer with a target location withinhead 90. Alignment system 110 also may provide quicker and more accuratereattachment of the TNS to head 90 to a same relative position withrespect to the target location. This allows TNS 100 to be repeatedlyreattached during multiple ultrasonic therapy sessions without using aMRI device to relocate the target location.

Side adjustment assemblies 120 each include a side adjustment knob 122that rotatably attaches to a side extension 124 that extends radial outfrom the side of outer housing 104. Top adjustment assembly 140 includesa top adjustment knob 142 that is rotatably attached to outer housing104. A threaded ring 146 extends out through the middle of topadjustment knob 142. A top end 144 of a transducer lid extends outthrough threaded ring 146 and a cap 148 inserts into a center cavity ofthe top end 144 of the transducer lid. Cap 148 operates as a wire guidefor receiving cable 116 and also operates as a stop for top end 144 ofthe transducer lid.

FIG. 1B shows opposite ends 113 of strap sections 108B and 108C. In oneexample, a hook and eye type material 107, such as Velcro®, may beattached to the ends of strap 108. For example, ends 113 of straps 108may include a hook material and may be fed through cinches 111. Strapends 113 are pulled to hold housing assembly 102 snugly against theopposite side of head 90. The hook material on strap ends 113 is thenattached to eye material 107.

Other attachment assemblies may be used for attaching ends 113 of straps108. For example, hook and eye buckles or ratchet buckles may be used onends 113 of straps 108. In yet another example, strap sections 108B and108C may be formed from elastic materials that are stretched and heldcompressively over head 90. Of course other attachment devices also maybe used.

In one example, straps 108 may be made out of leather. However, anymaterial may be used that can securely hold housing assembly 102 againstpatient 88. As just discussed, straps 108 may alternatively be anelastic plastic, rubber, or cloth material. Straps 108 may be availablein multiple lengths and sizes to attach to various patient head sizesand patient body parts for small children to large adults.

FIG. 2 shows a side view of TNS 100. Outer housing 104 comprises acircular outside surface 160 with two openings 162 that show a portionof inner housing 106 attached to side adjustment assemblies 120. Housingarms 112 extend radially out from the sides of outer housing 104 andoperate similar to a tri-pod allowing TNS 100 to be steadily supportedby elevating screws 114 on varying elevational locations on head 90.

Side adjustment assemblies 120 may each include inner adjustment screws(see FIG. 4) that have first ends that attach to inner housing 106 andsecond ends that attach to side adjustment knobs 122. Two threadedstationary pins 164 are located on sides of outer housing 104 oppositeadjustment assemblies 120. Pins 164 slidingly insert into sides of innerhousing 106 opposite the sides attached to side adjustment assemblies120.

Side adjustment knobs 122 can be rotated in both clockwise andcounterclockwise directions. For example, rotating either one of sideadjustment knobs 122 in a clockwise direction may cause the inneradjustment screw to rotate inward. The inner adjustment screw in turnmoves inner housing 106 away from side adjustment assembly 120 andtoward an opposite end of outer housing 104 and toward one of pins 164.Rotating one of side adjustment knobs 122 also causes knob 122 to moveradially inward over an outside surface of side extension 124 and towardan outside perimeter 105 of outer housing 104.

Rotating any combination of side adjustment knobs 122 in an oppositecounter clockwise direction may cause the inner adjustment screws torotate outward. The inner adjustment screw in turn may pull innerhousing 106 toward side adjustment assembly 120 and away from theopposite end of outer housing 104 where pin 164 is located. The counterclockwise rotation also may cause side adjustment knob 122 to moveradially outward over the outside surface of side extension 124 awayfrom outside perimeter 105 of outer housing 104.

Gradations 126 are imprinted on the outside surface of side extensions124. In one example, each gradation 126 may be spaced apart onemillimeter (mm). Gradations 126 in combination with side adjustmentknobs 122 operate as micrometers identifying distances of x and ymovement of the transducer contained inside of inner housing 106. Forexample, after TNS 100 is attached to the head of the patient, sideadjustment knobs 122 may be rotated to adjust the location of thetransducer so a focal point of ultrasonic energy is directed preciselyover a target area inside of the brain of the patient.

Top adjustment knob 142 is co-centrically positioned on top of outerhousing 104. Threaded ring 146 is concentrically positioned within topadjustment knob 142 and cap 148 is concentrically positioned within topend 144 of the transducer lid and over threaded ring 146. Rotating topadjustment knob 142 in a first direction may move top end 144 of thetransducer lid in an upward z direction away from the head of thepatient. Rotating top adjustment knob 142 in a second opposite directionmay move top end 144 of the transducer lid in a downward z directiontoward the head of the patient.

FIG. 3 shows a partial side cut away view of top adjustment assembly140. Top adjustment knob 142 has an oppositely inclining top wall 145Aand an inner side wall 145B that form an inner hole 152 that receivesthreaded ring 146. Screws (not shown) may insert into side walls 145Band rigidly couple adjustment knob 142 to threaded ring 146.

Rotating top adjustment knob 142 in the first direction also rotatesthreaded ring 146 causing top end 144 of the transducer lid to move inan upward z-direction away from the head of the patient. Rotating topadjustment knob 142 in the second opposite direction also rotatesthreaded ring 146 in the same direction moving top end 144 of thetransducer lid in a downward z-direction toward the head of the patient.

Gradations 150 may be imprinted on an outside surface of top end 144 ofthe transducer lid. In one example, gradations 150 also have onemillimeter spacing. Gradations 150 in relation to the location ofrotating knob 142 also operate as a micrometer identifying an amount ofmovement of the transducer in the z direction.

FIG. 4 shows a front sectional view of TNS 100. Inner housing 106comprises a top wall 132, side walls 134, a membrane clamping ring 136,and a hypo-allergenic flexible membrane 138 that together form a sealedinner housing chamber 174 configured to retain a transducer assembly165. In one example, chamber 174 may be sealed and filled with degassedoil or water to improve efficiency of transferring the ultrasound wavesthrough the skull and brain and into the target location.

Membrane 138 may be formed of a plastic or rubber material and isconfigured to elastically press up against the head of the patient. Thethreaded connection of clamping ring 136 to side walls 134 allowmembrane 138 to be detached from the rest of inner housing 106. Acushion 137 may be glued to the bottom of clamping ring to increasecomfort and conform around irregularities on the surface of the head ofthe patient. After completing the ultrasonic therapy sessions for apatient, membrane 138 may be removed and replaced with a new membranefor a next patient. A layer of gel may be spread over an outside surfaceof elastic membrane 138 and may maintain a continuous seal betweenmembrane 138 and the head of the patient as will be discussed in moredetail below in FIG. 8.

Transducer assembly 165 comprises a transducer 166 located between atransducer lid 170 and a transducer base 178. A space between transducer166 and transducer lid 170 forms an airtight sealed back cavity 168. Aspace between transducer 166 and transducer base 178 forms a sealedfront cavity 176 configured to retain water. A single transducer 166 isshown in FIG. 4. However, inner housing 106 and transducer assembly 165may be configured to retain any transducer shape and any number oftransducers, such as circular transducers and multi-transducer arrays.

Transducer lid 170 includes a neck 172 that extends up inner housing106, outer housing 104, and threaded ring 146. As shown above, top end144 of transducer lid 170 extends up through a top end of threaded ring146 and includes a threaded internal hole 198 configured to threadedlyreceive cap 148. Left hand threads may be formed on the outside surfaceof cap 148 to prevent cap 148 from being unscrewed if it bottoms outagainst the top of ring 146. A threaded outside surface of neck 172 isconfigured to threadedly engage with a threaded inside surface of ring146. Cable 116 extends through a hole in the center of neck 172 andwires from cable 116 are coupled to transducer 166.

As mentioned above, rotation of top adjustment knob 142 in a firstdirection rotates threaded ring 146 around threaded neck 172 movingtransducer assembly 165 in a first upward z direction toward top wall132 of inner housing 106. Rotation of top adjustment knob 142 in theopposite direction rotates threaded ring 146 around threaded neck 172 inthe opposite direction moving transducer assembly 165 in a seconddownward z direction toward membrane 138. Cap 148 operates as a stoppreventing top end 144 of transducer lid 170 from moving down below atop end of threaded ring 146.

An O-ring 156 is located between threaded ring 146 and top end 144 oftransducer lid 170. An O-ring 158 is located between threaded ring 146and the inside surface of a hole formed in top wall 132 of inner housing106. O-rings 156 and 158 are configured to maintain a watertight or oiltight seal within chamber 174 while threaded ring 146 is rotated aroundtransducer neck 172. An O-ring 200 may be located between the bottom endof side walls 134 and membrane clamping ring 136 to provide a watertightor oil tight seal along the bottom end of cavity 174.

Inner housing 106 may be made of a clear see-thru plastic that allows atechnician to visually detect any air bubbles that may exist in the oilor water within chamber 174. Two compression nozzles 202 may be mountedwithin side walls 134 of inner housing 106. Compression nozzles 202 maybe used for filling chamber 174 with water or oil and bleeding airbubbles out of chamber 174, similar to bleeding air out of vehiclebraking systems. For example, water may be forced into a first one ofnozzles 202. A second one of nozzles 202 may be depressed or unscrewedto bleed water and air bubbles from chamber 174. An indication that mostor all of the air bubbles are removed may be provided when only waterbleeds out of second nozzle 202. Inner housing 106 may be shaken duringthe bleeding process to promote the air bubbles to exit out of secondnozzle 202.

Each side adjustment assembly 120 may include an inner adjustment screw128 that forms a head 190 at a front end and is attached to a sideadjustment knob 122 at a back end. A sleeve 194 is inserted into a holeformed in the side of inner housing 106. Screw head 190 inserts androtates inside of sleeve 194. An alignment guide 182 is attached toinner housing 106 and includes a lip 193 that seats into a groove 192formed in screw head 190. A sleeve 196 inserts into a hole formed in anouter opposite side of inner housing 106. A front end of threadedstationary pin 164 slidingly inserts into sleeve 196 and a back end ofpin 164 threaded and rigidly attaches to outer housing 104. An alignmentguide 184 attaches to inner housing 106 and slidingly presses against atop side of the front end of pin 164.

Threads are formed on an inside surface of a hole formed inside of eachside extension 124 and engage with threads on screw 128. Rotating sideadjustment knob 122 in a first direction rotates screw 128 and moveshead 190 in a forward direction. Screw head 190 pushes inner housing 106away from side extension 124 toward the opposite side of outer housing104 while sleeve 192 on the opposite end of inner housing 106 slidesfurther over the front end of pin 164.

Rotating side adjustment knob 122 and screw 128 in an opposite directionmove head 190 in a reverse direction. Head 190 pulls lip 193 andattached inner housing 106 toward side extension 124 while sleeve 196 onthe opposite side of inner housing 106 moves further out from the frontend of pin 164.

Alignment guides 182 and 184 allow inner housing 106 to move into any xand y position. For example, adjustment screws 128 may move innerhousing 106 into different positions. Alignment guides 182 may slideover groves 192 on screw heads 190 and alignment guides 184 may slideover pins 164 allowing movement of inner housing 106 into any x and yposition within outer housing 104.

Operation Overview

Referring to FIGS. 1-4, patient 88 may have focused ultrasonictransducer navigation system (TNS) 100 strapped onto head 90 whileundergoing an MRI-assisted positioning procedure. An administratorcontrolling an electronic power source stimulator may be in a nearbyroom which is safe from the magnetic field produced by the MRI device.The administrator may use a functional MRI (fMRI) method that showsimages from inside of the brain of patient 88 and shows a target spotspecific for treatment of a particular disorder.

TNS 100 may send a Low Intensity Focused Ultrasound Pulse (LIFUP) intothe brain which can be seen and recorded on an fMRI console screen as achange in a BOLD signal. The resulting location of the ultrasonic pulseis measured relative to the spot targeted for treatment. Alternatively,the location may be verified by fMRI sequences that measure smalltemperature changes within the brain occurring as a result of the LIFUPstimuli.

The administrator slides patient 88 out from under the MRI device andadjusts side adjustment knobs 122 and top adjustment knob 142(micrometer dials) to move the focus of the LIFUP generated bytransducer 166 to the desired target location. The MRI comparisonprocedure is repeated until transducer 166 generates an ultrasonic pulsedirectly on the center of the target location in all three x, y, and zplanes. TNS 100 is then used to perform an ultrasonic treatment.

A medically approved pen is used to mark a portion of a circle aroundthe perimeter of inner movable housing 106 and on the head of patient88. In one example, inner housing 106 may be made from a clear plasticmaterial. Marking the head with the ink pen enables subsequenttreatments to be administered in the office of a doctor or technicianwithout having to use an expensive MRI device to repeatedly realign TNS100. Thus the time and cost per treatment may be significantly reduced.

The three elevating screws 114 may be adjusted to any size and shape ofhead 90 and in one example may use comfortable STERalloy Elastomericcushions 118. Elevating screws 114 raise membrane 138 slightly off head90 to facilitate the free movement of inner moveable housing 106 in thex and y planes. Side adjustment assemblies 120 may be used to aligninner housing 106 with the circle previously marked on the head ofpatient 88 centering ultrasonic energy generated by transducer 166 intothe center of the target within the brain.

When the x and y planes are on target, elevating screws 114 are backedoff to lower membrane 138 more firmly against head 90. A gel may beapplied to membrane 138. The gel may maintain a contact layer betweenmembrane 138 and head 90 while membrane 138 is moved to different x andy positions. The gel layer may prevent an air gap from forming betweenmembrane 138 and head 90 that could reduce efficiency of the focusedultrasound waves output by transducer 166.

After completion of the LIFUP treatments, the STERalloy elastomericcushions 118, membrane clamping ring 136 and membrane 138 may bereplaced. This may prevent allergies or other undesirable effects frombeing transferred to other patients. The LIFUP procedure may be welcomedby the insurance companies as compared to surgery which may be moreexpensive and higher risk.

Initial Alignment and Treatment

During the initial MRI alignment procedure described above, the focalpoint of ultrasonic energy output from transducer 166 is aligned asclosely as possible to the center of the target location. This allowsmore tolerance when realigning TNS 100 during subsequent treatments.

Referring to FIGS. 5 and 6, patient 88 may lie on their side and head 90may be shaved in the installation location for TNS 100. A target mark210 is applied to head 90 with an ink pen 204. A template 202 includes ahole 208 that is aligned over target mark 210, holes 206 that arealigned with the outside perimeter of inner housing 106, and two slots212 that are aligned with one of housing arms 112. Template 202 may bemade from a clear semi-rigid plastic material.

Template 202 is placed against head 90 so hole 208 aligns over targetmark 210 and slots 212 are located in a desired location for one ofhousing arms 112. While holding template against head 90, ink pen 204 isused to apply reference lines 214 to head 90 through slots 212 and applyreference marks 216 to head 90 through holes 206. Template 202 is thenremoved. The third middle reference mark in each column of fivereference marks 216 is alternatively referred to as a center referencemark 216A.

FIG. 7 shows a side view of TSN 100 and FIGS. 8 and 9 show frontsectional views of TNS 100. FIGS. 7, 8, and 9 shows in more detail howinner housing 106 may be moved into different x, y, and z locations toalign with a target location 220.

The x, y and z planes in TNS 100 may be set to nominal positions bysetting side adjustment knobs 122 and top adjustment knob 142 each to 6mm. Gel may be applied to the entire surface of membrane 138 and may beapplied so it does not exceed a perimeter 218 of inner housing 106.Perimeter 218 may comprise the outside perimeter of membrane clampingring 136.

Elevating screws 114 are raised as shown in FIG. 8 so membrane 138contacts head 90. TNS 100 is aligned on head 90 so center referencemarks 216A for each column of five reference marks 216 align withperimeter 218 as shown in FIG. 7. Housing arm 112A is aligned betweenreference lines 214 as shown in FIG. 7. TNS 100 is held firmly againsthead 90 to prevent movement and the ends of straps 108 are tightenedholding TNS 100 firmly against head 90.

Patient 88 is placed under the MRI device. A pulse 222 from transducer166 is transmitted into head 90 of patient 88 using the stimulator. TheMRI device identifies the pulse location relative to target location 220in the x and y planes. If the pulse location is off more than 6 mm inthe x or y planes, TNS 100 may be removed from head 90 and the threecolumns of five reference marks 216 used as a guide to realign TNS 100.

For example, reference marks 216 in each column may be spaced a knowndistance apart. Perimeter 218 of inner housing 106 may be aligned nextto a different set of reference marks 216 based on the identifieddistance between the focal point of ultrasonic pulse 222 and targetlocation 220. Patient 88 then may be placed back under the MRI deviceand the distance re-measured between the new focal point for theultrasonic pulse 222 and target location 220. The realignment procedureis repeated until the distance between ultrasonic pulse 222 and targetlocation 220 is less than 6 mm in both the x and y planes.

If the x and y locations of ultrasonic pulse 222 are both within 6 mm oftarget location 220, elevating screws 114 are screwed down as shown inFIG. 9 to raise inner housing 106 slightly off of head 90. Sideadjustment knobs 122 shown in FIG. 7 then may move inner housing 106inside of outer housing 104. The x and y positions of inner housing 106are adjusted based on the previously measured distance between theultrasonic pulse 222 and target location 220.

For example, the MRI device may determine ultrasonic pulse 222 is spaceda distance of 2 mms from target location 220 in an x direction. One ofside adjustment knobs 122 may be used to move inner housing 106 2 mms inthe x direction. The three elevating screws 122 then may be retractedupward again as shown in FIG. 8 so membrane 138 presses firmly backagainst head 90. Another ultrasonic pulse 222 is applied to patient 88and the x and y position of the new pulse measured in relation to targetlocation 220.

The z plane position of inner housing 106 may be adjusted after the xand y positions of ultrasonic pulse 222 are aligned on target location220. For example, a distance of ultrasonic pulse 222 from targetlocation 220 in the z direction is measured from the MRI images. Topadjustment knob 142 is rotated to move transducer assembly 165 up ordown by the measured z distance. Head 90 of patient 88 is then rescannedby the MRI device and the new location of ultrasonic pulse 222 iscompared with target location 220. The measurement and adjustmentprocess is repeated until the focal point of ultrasonic pulse 222 alignsover target location 220 in the x, y, and z planes. After alignment ofultrasonic pulse 222, TNS 100 may be checked to see if any gel isvisible around perimeter 218 of inner housing 106. Any seeping gel maybe wiped clean with a swab.

FIG. 7 shows a pen 204 used for tracing a reference line on head 90around as much of perimeter 218 as possible. The z setting of TNS 100may be recorded on a patient identification card. For example, alocation of the top end of threaded ring 146 with respect to gradations150 on top end 144 of transducer lid 170 may serve as the z referencelocation (see FIG. 3). The reference line traced around perimeter 218 ofinner housing 106 may serve as the x and y reference locations.

An initial ultrasonic treatment then may be applied to patient 88 usingTNS 100. After completion of the treatment session, TNS 100 may be wipedclean and placed back into a case. The same TNS 100 may be reserved forall subsequent ultrasonic treatments for the same patient.

Subsequent Alignments and Treatments

Reference marks 216, reference line 214 shown in FIG. 6, and theaddition reference line drawn around perimeter 218 of inner housing 106on head 90, may be visually inspected. Any faded reference marks orlines may be redrawn on head 90.

TNS 100 is adjusted to nominal x and y positions by setting sideadjustment knobs 122 each to 6 mm. Gel is again applied to the entiresurface of membrane 138. Perimeter 218 of inner housing 106 isconcentrically aligned as closely as possible with the reference linethat was previously traced around perimeter 218. Housing arm 112 in FIG.7 is also aligned between the reference lines 214. Outer housing 104extends down about half an inch over inner housing 106, but still allowsviewing of outside perimeter 218 of inner housing 106.

TNS 100 is held firmly against head 90 to prevent it from moving whilestraps 108 is again wrapped and tightened around head 90. If necessary,elevating screws 122 are rotated down from the position shown in FIG. 8to the position shown in FIG. 9 to raise inner housing 106 enough toslide over head 90 without moving outer housing 104. As mentioned above,the gel on membrane 138 may maintain a contact layer between membrane139 and head 90 as inner housing 106 is being adjusted in the x and ypositions. The elevating screws reduce pressure of membrane 138 againsthead 90 of patient 88 and allow membrane 138 to remain in contactagainst head 90 while inner housing 106 is moved into different x and ypositions.

The x and/or y positions of inner housing 106 are adjusted untilperimeter 218 visually aligns with the circular marked line previouslytraced around perimeter 218 as shown in FIG. 7. Elevating screws 122 arerotated upward as shown in FIG. 8 until they no longer touch head 90.The z location of inner housing 106 is verified by comparing the zsetting on gradation 150 (FIG. 3) with the z setting on the patientidentification card. If necessary, top adjustment knob 142 may berotated to establish the previous z setting on gradation 150.

An ultrasonic treatment may now begin without having to realigntransducer 166 using an MRI device. When the ultrasonic treatment iscomplete, TNS 100 can be wiped clean and placed back into the originalcase for the next use by patient 88.

TNS 100 is designed to receive a variety of different transducers thatcan generate ultrasonic energy into the brain or other body parts at avariety of different depths to accommodate a variety of differentdisorders. For example, TNS 100 may be used for treating psychiatricdisorders, such as depression, anxiety, Obsessive-Compulsive Disorder(OCD), bulimia, bipolar disorder, or autism. TNS 100 also may be used totreat a variety of neurological disorders, such as epilepsy,Parkinson's, Alzheimer's, and other dementias, coma, and brain injury.TNS 100 also may be used to treat medical conditions, such as high andlow blood pressure, obesity, and endocrine and immunological disease;and perform functional diagnostics of brain circuits.

The system described above can use dedicated processor systems, microcontrollers, programmable logic devices, or microprocessors that performsome or all of the operations. Some of the operations described abovemay be implemented in software, such as computer readable instructionscontained on a storage media, or the same or other operations may beimplemented in hardware.

For the sake of convenience, the operations are described as variousinterconnected functional blocks or distinct software modules. This isnot necessary, however, and there may be cases where these functionalblocks or modules are equivalently aggregated into a single logicdevice, program or operation with unclear boundaries. In any event, thefunctional blocks and software modules or features of the flexibleinterface can be implemented by themselves, or in combination with otheroperations in either hardware or software.

References above have been made in detail to preferred embodiment.Examples of the preferred embodiments were illustrated in the referenceddrawings. While preferred embodiments where described, it should beunderstood that this is not intended to limit the invention to onepreferred embodiment. To the contrary, it is intended to coveralternatives, modifications, and equivalents as may be included withinthe spirit and scope of the invention as defined by the appended claims.

Having described and illustrated the principles of the invention in apreferred embodiment thereof, it should be apparent that the inventionmay be modified in arrangement and detail without departing from suchprinciples. Claim is made to all modifications and variation comingwithin the spirit and scope of the following claims.

1. An apparatus, comprising: an outer housing configured to attach to a patient; and an inner housing attached to the outer housing and configured to retain a transducer, the inner housing further configured to move into different positions while the outer housing is attached to the patient.
 2. The apparatus of claim 1, wherein the outer housing comprises: arms extending out from side walls; and elevating screws extending through the arms and configured to press against the patient and lift the inner housing.
 3. The apparatus of claim 2, further comprising side adjustment assemblies configured to move the inner housing into the different positions while the elevating screws lift the inner housing.
 4. The apparatus of claim 3, wherein the side adjustment assemblies comprise: extensions extending from sides of the outer housing; and adjustment screws threadedly coupled inside of the extensions and configured to push and pull the inner housing.
 5. The apparatus of claim 4, wherein the side adjustment assemblies further comprise: gradations located on an outside surface of the side extensions; and side adjustment knobs attached to ends of the adjustment screws and configured to rotate the adjustment screws and identify on the gradations a distance of movement of the inner housing.
 6. The apparatus of claim 4, further comprising pins located on sides of the outer housing opposite the extensions, wherein the pins are slidingly retained inside of holes extending into sides of the inner housing.
 7. The apparatus of claim 1, wherein the inner housing further comprises: a top end configured to slide against the outer housing; and a bottom end having a flexible membrane configured to press against the patient.
 8. The apparatus of claim 1, wherein the inner housing forms an internal chamber for retaining water or oil.
 9. The apparatus of claim 8, further comprising nozzles extending through side walls of the inner housing, wherein the nozzles are configured to fill the internal chamber with the water or oil and bleed air bubbles from the internal chamber.
 10. The apparatus of claim 1, further comprising a transducer assembly configured to move the transducer within the outer housing.
 11. The apparatus of claim 10, wherein the transducer assembly further comprises: a transducer lid forming an airtight cavity on a back side the transducer; and a transducer base coupled to the transducer lid and forming a watertight cavity over a front side of the transducer configured to retain water.
 12. The apparatus of claim 11, wherein the transducer assembly further comprises a neck extending up from the transducer lid through the inner housing and the outer housing.
 13. The apparatus of claim 12, further comprising a threaded ring extending up through the inner housing and the outer housing and including a threaded inside surface configured to engage with threads formed on an outside surface of the neck.
 14. The apparatus of claim 13, further comprising gradations formed on the outside surface of the neck, wherein a position of the threaded ring over the gradations identifies a distance of movement of the transducer.
 15. The apparatus of claim 13, further comprising a first O-ring located between the threaded ring and the outside surface of the neck and a second O-ring located between the ring and a top wall of the inner housing.
 16. The apparatus of claim 13, further comprising a top adjustment knob located on top of the outer housing and coupled around the threaded ring, the top adjustment knob configured to rotate the threaded ring to control movement of the transducer assembly inside of the inner housing.
 17. The apparatus of claim 13, further comprising a cap threadedly coupled into a top end of the neck and extending over the threaded ring.
 18. The apparatus of claim 1, further comprising straps configured to hold the outer housing and inner housing to the patient, wherein the outer housing is configured to lift the inner housing over the patient while the straps hold the outer housing to the patient.
 19. The apparatus of claim 1, further comprising a flexible membrane coupled to a front face of the inner housing configured to maintain contact against the patient while the inner housing is moved into the different positions.
 20. A method, comprising: identifying a target location in a patient; attaching a housing to the patient, wherein the housing contains a therapy device; using an elevating mechanism to raise the housing while the housing is attached to the patient; using a first adjustment assembly to move the housing so a focal point of energy from the therapy device is in an x, y plane alignment with the target location in the patient; using the elevating mechanism to lower the housing; and using a second adjustment assembly to move the focal point of the energy from the therapy device in a z plane alignment with the target location.
 21. The method of claim 20, further comprising: using a template to apply reference marks on the patient; aligning the housing with the reference marks on the patient; and strapping the housing to the patient while the housing is aligned with the reference marks.
 22. The method of claim 20, further comprising: tracing a reference line around a perimeter of the housing and onto the patient after the focal point of the energy from the therapy device is in the x, y, and z plane alignments with the target location in the patient.
 23. The method of claim 22, further comprising: applying a first procedure to the patient using the therapy device; removing the housing from the patient; aligning the housing with the reference line on the patient; strapping the housing back onto the patient; refining the x and y plane alignments of the housing with the reference line using the first adjustment assembly while the housing is strapped to the patient; and applying a second procedure to the patient using the therapy device.
 24. The method of claim 23, further comprising using the second adjustment assembly to realign the focal point of the energy from the therapy device in the z-plane with the target location.
 25. The method of claim 20, further comprising: applying a layer of gel to a flexible membrane attached to a front end of the housing; using the elevating mechanism to lift the housing off of the patient while the layer of gel remains in contact between the membrane and the patient; and using the first adjustment assembly to move the housing while the layer of gel remains in contact between the membrane and the patient.
 26. An apparatus, comprising: a housing configured to retain an ultrasonic device; an attachment mechanism configured to attach the housing to a patient; and an alignment system configured to move the ultrasonic device in different x and y positions while the housing is attached to the patient.
 27. The apparatus of claim 26, wherein the alignment system is further configured to move the ultrasonic device in different z positions while the housing is attached to the patient.
 28. The apparatus of claim 27, wherein the alignment system comprises: an assembly retaining the ultrasonic device, wherein the assembly includes a neck extending thru the housing; and a collar extending around the neck configured to move the assembly inside of the housing.
 29. The apparatus of claim 26, wherein the alignment system is configured to identify a distance of movement of the ultrasonic device.
 30. The apparatus of claim 27, further comprising a flexible membrane coupled to the housing configured to maintain contact with the patient while the housing is moved into the different x, y, and z positions.
 31. The apparatus of claim 30, further comprising an elevating mechanism configured to lift the housing while the flexible membrane maintains contact with the patient and the ultrasonic device is moved into the different x and y positions.
 32. The apparatus of claim 31, wherein the elevating mechanism comprises: a platform slidingly coupled to the housing; arms extending out from the platform; and elevating screws extending through the arms.
 33. The apparatus of claim 32, wherein the alignment system further comprises adjustment screws extending through sides of the platform configured to move the housing into different x and y directions.
 34. The apparatus of claim 33, further comprising side adjustment knobs attached to ends of the adjustment screws configured to identify a distance of movement of the ultrasonic device for the different x and y positions. 